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Quality Assurance Specialist
Location: Chester County, PA | Hybrid
Organization Type: High-volume compounding pharmacy
Requirements
- Approximately 10+ years of progressive experience in pharmaceutical Quality Assurance, sterile drug production, pharmaceutical operations, or a high-volume compounding pharmacy environment strongly preferred.
- Strong hands-on experience with deviations, investigations, CAPAs, root-cause analysis, Quality Management Systems (QMS), and compliance processes.
- Working knowledge of sterile compounding and applicable regulatory requirements, including USP standards, FDA regulations, GMP principles, and state Board of Pharmacy requirements.
- Experience working within a regulated 503A compounding pharmacy, 503B outsourcing facility, sterile pharmaceutical manufacturing, or similar production environment highly desirable.
Job Duties
- Maintain an active Quality presence across sterile and nonsterile compounding, cleanroom, dispensing, fulfillment, packaging, and supporting pharmacy operations.
- Conduct routine floor observations to ensure day-to-day practices align with established SOPs, training, documentation standards, and quality controls.
- Identify procedural deviations, documentation deficiencies, inconsistent practices, and potential compliance or patient-safety risks in real time.
- Provide hands-on Quality guidance and coaching to pharmacists, pharmacy technicians, supervisors, and operational staff.
- Initiate and support deviations, investigations, root-cause analyses, CAPAs, risk assessments, and change controls through resolution.
- Monitor recurring quality events and trends, recommending sustainable corrective and preventive actions to strengthen operations.
- Support inspection readiness and continuous improvement efforts while partnering closely with Operations, Compliance, Training, and Quality leadership.
Additional Information
- Schedule: Monday-Friday, 8:00 AM-4:30 PM
- Work Arrangement: Hybrid, with 2-3 days onsite per week in Chester County, PA
- Pay Range: Up to $110,000/annually
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